Good Laboratory Practices for Designing Toxicology Studies for Petition Submissions and Notifications
21 CFR Part 58

Guidance for Submitting Petitions and Notifications

The guidance documents listed below have been prepared to assist in the design of protocols for animal studies conducted to test for the safety of food ingredients.

21 CFR Part 58 - Good Laboratory Practice for Nonclinical Laboratory Studies
Subpart A - General Provisions	21 CFR Part 58.1	Scope
	21 CFR Part 58.3	Definitions
	21 CFR Part 58.10	Applicability to studies performed under grants and contracts
	21 CFR Part 58.15	Inspection of a testing facility
Subpart B - Organization and Personnel	21 CFR Part 58.29	Personnel
	21 CFR Part 58.35	Testing facility management
	21 CFR Part 58.31	Study director
	21 CFR Part 58.33	Quality assurance unit
Subpart C - Facilities	21 CFR Part 58.41	General
	21 CFR Part 58.43	Animal care facilities
	21 CFR Part 58.45	Animal supply facilities
	21 CFR Part 58.47	Facilities for handling test and control articles
	21 CFR Part 58.49	Laboratory operation areas
	21 CFR Part 58.51	Specimen and data storage facilities
Subpart D - Equipment	21 CFR Part 58.61	Equipment design
Subpart D - Equipment	21 CFR Part 58.63	Maintenance and calibration of equipment
Subpart E - Testing Facilities Operation	21 CFR Part 58.81	Standard operating procedures
	21 CFR Part 58.83	Reagents and Solutions
	21 CFR Part 58.90	Animal care
Subpart F - Test and Control Articles	21 CFR Part 58.105	Test and control article characterization
	21 CFR Part 58.107	Test and control article handling
	21 CFR Part 58.113	Mixtures of articles with carriers
Subpart G - Protocol for and Conduct of a Nonclinical Laboratory Study	21 CFR Part 58.120	Protocol
	21 CFR Part 58.130	Conduct of a nonclinical laboratory study
Subpart J - Records and Reports	21 CFR Part 58.185	Reporting of nonclinical laboratory study results
	21 CFR Part 58.190	Storage and retrieval of records and data
	21 CFR Part 58.195	Retention of records
Subpart K - Disqualification of Testing Facilities	21 CFR Part 58.200	Purpose
	21 CFR Part 58.202	Grounds for disqualification
	21 CFR Part 58.204	Notice of and opportunity for hearing on proposed disqualification
	21 CFR Part 58.206	Final order on disqualification
	21 CFR Part 58.210	Actions upon disqualification
	21 CFR Part 58.213	Public disclosure of information regarding disqualification
	21 CFR Part 58.215	Alternative or additional actions to disqualification
	21 CFR Part 58.217	Suspension or termination of a testing facility by a sponsor
	21 CFR Part 58.219	Reinstatement of a disqualified testing facility

Guidance for Submitting Petitions and Notifications

Whom to Ask for Help

Food Ingredients and Packaging

FDA/Center for Food Safety & Applied Nutrition
Hypertext updated by emw November 10, 2005

Good Laboratory Practices for Designing Toxicology Studies for Petition Submissions and Notifications 21 CFR Part 58

Good Laboratory Practices for Designing Toxicology Studies for Petition Submissions and Notifications
21 CFR Part 58